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This device, an all-polyethylene patella, is intended to be used with the Duracon® femoral and tibial components as a total knee system. This component is intended to be used in the primary and/or revision replacement of the articular surface of the patella.

This device, an all-polyethylene patella, is intended to be used with the Duracon® femoral and tibial components as a total knee system. This component is intended to be used in the primary and/or revision replacement of the articular surface of the patella.

Here's an analysis of the provided text regarding the Duracon® All Polyethylene Patella II, focusing on acceptance criteria and study details.

Based only on the provided text, the information is very limited regarding detailed acceptance criteria and a definitive study proving the device meets them in a robust, quantitative manner. The document is an FDA 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to legally marketed devices, rather than presenting a comprehensive clinical trial.

Here's the breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• The document mentions "Patello-femoral contact area and lateral stability testing were presented."
• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It sounds like in-vitro mechanical testing rather than clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. The "testing" mentioned appears to be mechanical/biomechanical, not expert-adjudicated clinical data.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study involving human readers or interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This device is a physical implant, not an AI or diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

• Not applicable. This is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

• For material specifications: ASTM Specification F 648 (a recognized industry standard).
• For patello-femoral contact area and lateral stability: Likely biomechanical measurements/simulations against pre-defined engineering targets or comparisons to predicate devices. The specific ground truth (e.g., a specific numerical range) is not provided.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable.

Summary and Limitations of the Provided Information:

The provided text is a 510(k) Pre-market Notification, which primarily focuses on demonstrating "substantial equivalence" to existing, legally marketed devices. It emphasizes:

• Similarity in Intended Use, Material, Design, and Operational Principles: The core argument for this 510(k) is that the new Duracon® All Polyethylene Patella II is fundamentally similar to several predicate devices already on the market from the same manufacturer.
• Material Conformance: Explicitly states the use of Ultra-High Molecular Weight Polyethylene conforming to ASTM Specification F 648. This is a key "acceptance criterion" met.
• Limited Performance Data: While "Patello-femoral contact area and lateral stability testing were presented," no specific quantitative results, methodologies, or acceptance thresholds for this testing are provided in this summary document. This suggests that the detailed results were submitted to the FDA but are not part of this public-facing notification summary.

To fully answer your questions with quantitative data, one would need access to the full 510(k) submission, including the detailed test reports for patello-femoral contact area and lateral stability, along with the specific acceptance criteria defined for those tests. The current document is a high-level summary.

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